November 2016 – The Election’s Impact on Medicare, New Nursing Home Requirements of Participation and Other Issues

It’s no surprise that the election has left many of us worried and disoriented. But we’ll regroup.

We may not understand where we’ve landed, but we’ll acclimate and march forward – with hope.

We hope the new administration will realize how today’s families are balancing – often barely – all the responsibilities they face at home and work. We hope they’ll think about the sick kids, older and disabled people who need health care and what it’s like for them and their caregivers when they can’t afford it, or can’t navigate our health insurance maze. We hope the administration will consider their needs, before the profits of insurance and pharmaceutical companies.

We hope they’ll remember why Medicare was enacted and how best to ensure it helps today’s beneficiaries as well as coming generations. We needed Medicare because private insurance failed to cover 50% of older people. We hope they won’t turn back history by giving Medicare away to that private insurance world, a world that didn’t, and doesn’t, want to insure people who most need health care. (read more…)

THE ELECTION’S POTENTIAL IMPACT ON MEDICARE

In January 2017, Donald Trump will be inaugurated as our nation’s 45th president. Both the House and Senate in the new 115th Congress will remain in Republican control, now with a Republican president. Although much remains unclear about specific policies that the new administration will pursue, it is very likely that health care will play a prominent role, given both statements on the campaign trail and pre-existing positions of Congressional leadership, including Speaker Paul Ryan.

Things to look out for:

Affordable Care Act (ACA) – both President-elect Trump and Republican leadership in Congress have vowed to repeal the ACA

Does “repeal” means all or select provisions?

Will there be a “replacement” and, if so, what might it look like?

Would the provisions affecting Medicare remain?

E.g., payment reforms that extended solvency of Part A trust fund, closing of donut hole, coverage of preventive services, etc.

Medicaid Expansion – would it be rolled back in states that have moved forward?

The Centers for Medicare & Medicaid Services has just released a comprehensive revision of federal nursing facility regulations. The regulations and explanatory material (over 700 pages total) are available here. The positives for nursing facility residents include expanded training requirements, and a new provision that an initial care plan be developed and implemented within 48 hours. The negatives include a failure to improve nurse staffing standards, and weakening the regulations limiting antipsychotic drug use.

Some important provisions are highlighted below. Additional analysis of the regulations will be developed in coming weeks by Consumer Voice, the Center for Medicare Advocacy, and Justice in Aging.

Quality of Care

Staffing: Although inadequate staffing is the greatest problem in nursing facilities today, the new regulations do not include a minimum staffing standard or a requirement for a 24-hour Registered Nurse. Instead, the new regulations continue current policy: requiring “sufficient” staffing levels, and registered nurse presence for eight hours daily. Staff must have “appropriate competencies and skills sets,” and staffing levels must take into consideration the number, acuity and diagnoses of the resident population, based on a newly mandated facility assessment.

Person-centered care: The previous regulations required that care be individualized, and based on a care plan, but the new regulations add emphasis. The new regulations define person-centered care and require that facilities learn more about who the resident is as a person, provide greater support for resident preferences, and give residents increased control and choice.

Care planning: Under the new regulations, facilities must develop and implement a baseline care plan for a new resident within 48 hours of admission. The care planning process itself calls for greater resident involvement and participation. In addition, the certified nursing assistant responsible for the resident, and a member of the food and nutrition services staff must participate in the care planning process.

Abuse, neglect and exploitation: Provisions related to abuse, neglect and exploitation are now included in a separate section, which brings more attention and focus to these issues. New protections include prohibiting licensed individuals with a disciplinary action from being hired, and requiring that suspicion of a crime be reported to law enforcement and the state survey and certification agency.

Antipsychotic drugs: Many residents with dementia are inappropriately given harmful antipsychotic drugs, despite strong current federal rules. The new regulations water down existing protections by folding antipsychotic drugs into a broader category of psychotropic drugs, and moving them from quality of care regulations to pharmacy services.

Training: Training requirements have been expanded to apply to all staff, contractual employees, and volunteers. Mandatory topics include communication, residents’ rights, and abuse, neglect and exploitation. Certified nursing assistants will be required to receive training on dementia management and resident abuse prevention.

Resident Rights

Prohibiting Pre-Dispute Arbitration: Currently, many nursing facility admission agreements include provisions obligating the resident to have disputes adjudicated through private arbitration. Such “pre-dispute” arbitration agreements now will be prohibited. Arbitration agreements will be allowed only when the events at issue occurred before the arbitration agreement was signed.

Improvements to Involuntary Transfer-Discharge Procedures: The new regulations specify that transfer-discharge for non-payment is inappropriate when the resident has submitted necessary paperwork to a third-party payor (such as Medicaid), and that payor is now evaluating the claim for payment. Also, facilities now will be obligated to send a copy of each transfer-discharge notice to the state’s long-term care ombudsman program, which is available to advise the resident.

Limiting Facility’s Ability to “Dump” Resident at Hospital: In an effort to evade transfer-discharge requirements, some facilities “dump” residents by refusing to readmit them from hospitalizations. To address the problem, the new regulations explicitly require a facility to follow the transfer-discharge procedures when the facility claims that a hospitalized resident cannot return to the facility.

Modifying Residents’ Rights to Have Visitors: The new regulations continue current law providing each resident with a right to receive visitors at any time. In an unwelcome change, however, if a visitor is not a family member, the right to receive a visit now is “subject to reasonable clinical and safety restrictions,” as set forth in facility policy.

Grievances: Far too often, complaints from residents and families have been dismissed or not taken seriously. The regulations will now call for facilities to have a grievance policy and a grievance official to oversee the grievance process. Complainants will receive a written grievance decision that includes the steps taken to investigate, a summary of the finding or conclusions, a statement as to whether the grievance was confirmed or not confirmed, and the action taken or to be taken by the facility.

REVIEW: HOME HEALTH BENEFIT – DIMINISHING ACCESS TO CARE

Overview

As discussed during previous Alliance calls, the Center has been hearing from people who meet Medicare coverage criteria but are unable to access Medicare-covered home health care, or the appropriate amount of care.

In particular, people living with long-term and debilitating conditions find themselves facing significant access problems. For example, patients have been told Medicare will only cover one to five hours per week of home health aide services, or only one bath per week, or that they aren’t homebound (because they roam outside due to dementia), or that they must first decline before therapy can commence (or recommence). Consequently, these individuals and their families are struggling with too little care, or no care at all.

Home health access problems have ebbed and flowed over the years, depending on the reigning payment mechanisms, systemic pressures, and misinformation about Medicare home health coverage. Regrettably, if recent policies and proposed rules are fully implemented, it appears these access problems will only get worse.

The Center recently met with CMS Administrator Sean Cavanaugh to discuss these issues and concerns. Through this meeting, CMS has invited us to further discussion of impediments to access.

The final home health rule updates the payment rates and the case-mix weights for 2017. Areas of significant change and concern to advocates are as follows:

Payment for high-cost outlier episodes of care will be based on visit length rather than the current cost-per-visit calculation, thus making it more difficult for individuals who need brief encounters at home to obtain care.

Payment for Negative Pressure Wound Therapy (NPWT) using a disposable device may be obtained outside of the HH PPS bundled payment. This will drive the result of more providers using disposable NPWT devices and likely encourage home health agencies to provide more services to users of NPWT.

Home Health Value Based Purchasing (HHVBP) continues to move forward since its implementation in January 2016. Increases in payments to providers based on HHVBP will continue to grow over the next several years. HHVBP creates incentives for increased home health payments based on narrowly defined achievements of “quality care.”

Home Health Quality Reporting Program adopted new quality measures that will create further impediments to access home health coverage for those most at risk for hospital readmission or death.

Pre-Claim Review

Medicare home health pre-claim review demonstration project began in Illinois on August 3, 2016.

Due to concerns experienced in Illinois, implementation of pre-claim review in Florida, Texas, Michigan and Massachusetts has been delayed for a year.

The National Association of Home Health and Hospice (NAHC) has filed a lawsuit against CMS (October 2016) for their “failed pre-claim review experiment”. NAHC told members that the case will be won when it is proven that pre-claim review harms patients, and not just home health agencies.

Advocates in Illinois should monitor access problems this demonstration project may result in for beneficiaries.

ADMINISTRATION ON COMMUNITY LIVING GRANT – FOR MEDICARE BENEFICIARIES UNDER AGE 65

An update on the activity generated by Center’s Administration for Community Living grant to expand SHIP/SMP outreach opportunities to Medicare beneficiaries Under Age-65:

The Center has a web-page on the Center’s website (www.MedicareAdvocacy.org) dedicated to issues for people who are under the age of 65 and who are eligible for Medicare benefits. This web-page is available to SHIPs and SMPs and all beneficiaries and advocates of beneficiaries who are looking for information to Medicare beneficiaries who are under age 65. Currently the web-page includes resources and events that will benefit this hard-to-reach population. It also includes information on past webinars and upcoming webinars on topics of particular interest or need for individuals who are under 65 and eligible, or becoming eligible, for Medicare.

In addition, the webinar entitled “An Overview of Eligibility, Enrollment and Payment” has been translated into Spanish and will be posted to the project web page in the near future. We are also seeking a Vietnamese translation of the presentation.

The Center is developed a new survey with the American Association of People with Disabilities (AAPD) to reach the individuals the project seeks to serve and address their needs. This resulted in the identification of two specific questions that we will be pushing out on Social Media.

Barrows v. Burwell (formerly Bagnall v. Sebelius), No. 3:11-cv-1703 (D. Conn.) (Observation Status). In November 2011, the Center for Medicare Advocacy and Justice in Aging filed a class action lawsuit on behalf of individuals who have been denied Medicare Part A coverage of hospital and nursing home stays because their care in the hospital was considered “outpatient observation” rather than an inpatient admission. When hospital patients are placed on observation status, they are labeled “outpatients,” even though they are often on a regular hospital floor for many days, receiving the same care as inpatients. Because patients must be hospitalized as inpatients for three consecutive days to receive Medicare Part A coverage of post-hospital nursing home care, people on observation status do not have access to nursing home coverage. They must either privately pay the high cost of nursing care or forgo that skilled care. The number of people placed on observation status has greatly increased in recent years.

On September 23, 2013, a federal judge in Connecticut granted the government’s motion to dismiss the lawsuit. Plaintiffs appealed, but limited the appeal to the issue of the right to an effective notice and review procedure for beneficiaries placed on observation status.

On January 22, 2015, a three-judge panel of the U.S. Court of Appeals for the Second Circuit decided that Medicare patients who are placed on observation status in hospitals may have an interest, protected by the Constitution, in challenging that classification. The panel held that the district court erred when it dismissed the plaintiffs’ due process claims, and it sent the case back to that court for further proceedings. Barrows v. Burwell, 777 F.3d 106 (2d Cir. 2015).

The parties have completed discovery on the question of whether plaintiffs have a “protected property interest” in Part A coverage of their hospital stays, such that they would have due process rights. Plaintiffs received voluminous documentation from the government and conducted depositions of witnesses from the Department of Health and Human Services, Medicare contractors, and some of the hospitals that treated the named plaintiffs. The law firm of Wilson Sonsini Goodrich & Rosati, which has helped the Center in previous litigation, provided pro bono assistance

Update: Briefing on cross motions for summary judgment and defendant’s supplemental motion to dismiss was completed as of November 2, 2016.

Exley v. Burwell (formerly Lessler v. Burwell), No. 3:14-cv-1230 (D. Conn.) (ALJ Delays) The Medicare statute and regulations require that an administrative law judge (ALJ) issue a decision within 90 days the filing of a request for hearing. While the Chief ALJ has stated that individual beneficiary cases should not be delayed, still most of the Center’s cases were exceeding statutory timelines for decisions.

On August 26, 2014, the Center filed a nationwide class action lawsuit in United States District Court in Connecticut. The named plaintiffs, from Connecticut, New York and Ohio, all waited longer than the statutory 90-day limit for a decision on their Medicare appeals.

On January 29, 2015, defendant’s motion to dismiss was denied. On June 10, 2015, the court granted the plaintiffs’ motion for certification of nationwide class of Medicare beneficiaries who have been or will be waiting more than 90 days for a decision on their timely-filed request for an ALJ hearing. The parties also conducted discovery. In March 2016 the court preliminarily approved a settlement and notice to the class was posted.

A Fairness Hearing was held on August 1, 2016 and the Court granted final approval of the settlement agreement. The settlement calls for the Office of Medicare Hearings and Appeals (OMHA) to continue its policy of providing beneficiary appellants with priority over other appellants in receiving ALJ decisions, to designate a Headquarters Division Director to oversee inquiries about appeals initiated by beneficiary appellants, and to address any complaints or questions concerning the processing of those appeals. OMHA will also introduce a new, more user-friendly ALJ hearing request form that allows beneficiaries to self-identify, and will also publish data about the length of processing time for beneficiary appeals.

On September 1, 2016 as part of the settlement, OMHA established a toll-free Beneficiary Help Line: (844) 419-3358. This line, which is staffed by representatives of OMHA, will address inquiries about ALJ appeals being pursued by Medicare beneficiaries. The Center urges anyone pursuing a beneficiary appeal who believes the appeal is not receiving timely attention to call the Beneficiary Help Line. The expectation is that a call to this line will help resolve delays in cases that are eligible to be prioritized. The Beneficiary Help Line is staffed from 8:00 a.m. to 4:30 p.m., Eastern Time. If calling at other times or if the OMHA Beneficiary Help Line staff are assisting other callers, OMHA instructs callers to leave a voicemail. Please report your experiences using the Help Line to the Center at: abers@medicareadvocacy.org.

Update: As part of the settlement, as of November 1, 2016 CMS updated scripts for 1-800-Medicare to highlight the OMHA beneficiary prioritization policy for beneficiary callers and to refer them to the toll-free OMHA Beneficiary Help Line if they have questions about filing appeals with OMHA or about ALJ appeals that are pending with OMHA. OMHA also posted the beneficiary appeals data required by the settlement on their website at http://www.hhs.gov/about/agencies/omha/about/current-workload/beneficiary-appeals-data/index.html. The data shows beneficiary appeals now being processed within or very close to the 90-day statutory time period. Revised ALJ hearing request forms that will make it easier for beneficiaries to identify themselves are scheduled to be released by February 1, 2017.

Jimmo v. Sebelius, No. 5:11-cv-17 (D. Vt.) (Improvement Standard). As reported during previous Alliance calls, the settlement in Jimmo was approved on January 24, 2013 during a fairness hearing. CMS issued revisions to its Medicare Benefit Policy Manual to clarify that Medicare coverage is available for skilled maintenance services in the home health, nursing home and outpatient settings. CMS also implemented a nationwide Educational Campaign for all who make Medicare determinations to ensure that beneficiaries with chronic conditions are not denied coverage for critical services because their underlying conditions will not improve. Pursuant to the settlement, counsel for the parties have been meeting twice a year to discuss problems with implementation and possible solutions, and are in regular contact between meetings.

On March 1, 2016, the Center and its co-counsel, Vermont Legal Aid, filed a Motion for Resolution of Non-Compliance with the settlement agreement. Oral argument was held on May 26, 2016. The filing came after three years of urging the Centers for Medicare & Medicaid Services (CMS) to fulfill its obligation to end continued application of an “Improvement Standard” by Medicare providers, contractors and adjudicators to deny Medicare coverage for skilled maintenance nursing and therapy.

If truly implemented and enforced, the settlement should improve access to skilled maintenance nursing and therapy for thousands of older adults and people with disabilities whose Medicare coverage for skilled care is denied or terminated because their conditions are “chronic,” “not improving,” “plateaued,” or “stable.” Unfortunately, providers and contractors continue to illegally deny Medicare coverage and care based on an “Improvement Standard,” resulting in beneficiaries nationwide failing to obtain needed skilled nursing and therapy coverage.

The court announced its decision on the Motion for Resolution of Non-Compliance on August 18, 2016. The Order requires CMS to remedy the inadequate Educational Campaign that was a cornerstone of the original Settlement Agreement. As the judge stated, “Plaintiffs bargained for the accurate provision of information regarding the maintenance coverage standard and their rights under the Settlement Agreement would be meaningless without it.” CMS must submit its proposed “corrective action” to plaintiffs’ counsel for consideration by October 3, 2016. If the parties cannot agree to that corrective action, they may petition the court for a resolution of their dispute.

Update: CMS submitted its proposed corrective action plan to plaintiffs’ counsel and the parties are now in negotiations over the plan. A status conference with the court is scheduled for November 18, 2016.

Sherman v. Burwell (formerly Olsen-Ecker v. Burwell), No. 3:15-cv-1468 (D. Conn.) (Lower level Medicare appeals) On October 9, 2015, the Center filed a complaint in United States District Court in Connecticut against Sylvia Mathews Burwell, Secretary of Health and Human Services, on behalf of plaintiffs who have been denied a meaningful review of their Medicare claims at the first two levels of appeal. The case was brought as a class action on behalf of Medicare beneficiaries seeking home health care coverage, and the named plaintiff represents beneficiaries who have received the usual “rubber stamp” denials at redetermination and reconsideration. The plaintiff also filed a motion for class certification, and the government filed a motion to dismiss. Written discovery was served but responses were stayed while the motion to dismiss was pending. Oral argument was held on February 29, 2016.

On August 8, 2016, the judge largely denied the government’s motion to dismiss and granted plaintiff’s motion for certification of a nationwide class. The court concluded that it had jurisdiction, rejecting the Secretary of Health and Human Services’ argument that all administrative remedies must be exhausted. It also decided that the case was not moot even though plaintiff’s claim had ultimately been approved. The judge dismissed the statutory claim, but found that plaintiff had stated a valid claim for relief under the Due Process Clause. He found plaintiff’s claim of a “secret policy” leading to the denial rate sufficiently plausible to allow the case to continue to discovery. The judge also certified a nationwide class of Medicare beneficiaries of home health care services who had received adverse decisions at the first two levels of appeal on their Part A or Part B claims, and who had received an initial adverse initial determination on or after January 1, 2012.

Update: Plaintiffs have received the government’s written responses and objections to discovery inquiry and await document production. Discovery is expected to continue through May 2017.

Ryan v. Burwell, No. 5:14-cv-269 (D. Vt.) (Prior Favorable Homebound Determination) On December 19, 2014, the Center for Medicare Advocacy and Vermont Legal Aid filed a class action lawsuit against Sylvia Mathews Burwell, the Secretary of Health and Human Services, to stop Medicare’s practice of repeatedly denying coverage for home health services for beneficiaries on the basis that they are allegedly not homebound, when Medicare has previously determined them to be homebound. (Ryan v. Burwell). The lawsuit was filed in the United States District Court in Burlington, Vermont on behalf of two Vermont residents, Marcy Ryan and John Herbert, as a regional class action lawsuit covering New England and New York.

On March 25, 2015, the government filed a motion to dismiss on the grounds that plaintiffs lack standing, that the court lacks subject matter jurisdiction, and that plaintiffs have failed to state claim on which relief may be granted. On July 27, 2015, the court denied the government’s motion to dismiss, finding four separate grounds on which the dually eligible plaintiffs have standing. The court also found that it had subject matter jurisdiction and that plaintiffs had stated a claim on which relief could be granted.

On December 2, 2015, the court granted plaintiffs’ motion for class certification and, at request of the plaintiffs, issued clarification on the class definition on February 23, 2016. The regional class is defined as all beneficiaries of Medicare Part A or B in Connecticut, Maine, Massachusetts, New Hampshire, New York, Rhode Island, and Vermont (Medicare Administrative Contractor Jurisdiction K): (a) who have received a “favorable final appellate decision” that he or she was “confined to the home,” i.e. homebound, in the appeal of a home health nursing or therapy claim denial; (b) who have subsequently been denied, or will be denied, coverage for additional service on the basis of not being homebound, on or after January 1, 2010; (c) who had a non-lapsed, viable appeal of the subsequent denial for coverage of additional home health services as of March 5, 2015, or had a particularized individual basis for tolling of any applicable appeal deadline; and (d) for whom the claim for Medicare home health coverage was filed on or before August 2, 2015. Written discovery was served.

Update: Preliminary settlement talks have stalled and the government may be filing a motion for summary judgment in November 2016.

Lodge v. Burwell, No. 3:15-cv-390 (D. Conn., filed 3/17/2015) (Medically necessary oral health care). This appeal filed in federal court, District of Connecticut, presents an opportunity for the court to review whether surgical treatment to a Medicare beneficiary’s teeth damaged by radiation therapy to the head and neck was 1) properly characterized by an Administrative Law Judge as a covered physician service that was medically reasonable and necessary as a part of an overall plan of care for cancer or 2) improperly characterized by the government contractor as excluded dental services. These competing interpretations depend upon how the specific treatment is characterized. The plaintiff amended the complaint on June 30, 2015 to add a claim under the Administrative Procedure Act (APA), stating that in 1974 the agency removed the word “routine” from the description of excluded dental services without following proper notice-and-comment procedure. Plaintiff requests that the court therefore read the relevant regulation as if the word “routine” had never been removed, which would allow for coverage of his extraordinary, non-routine oral health care.

The government filed a partial motion to dismiss in October 2015. The motion sought to dismiss the APA claim as barred by the statute of limitations. However after the motion was briefed, the government requested and was allowed to withdraw the partial motion to dismiss. The parties also conducted limited written discovery.

Update: Oral argument on the merits of the case was conducted on September 23, 2016 and the parties are waiting for a decision from the court.

Bremby v. Burwell, No. 3:15-cv-1397 (D. Conn.)(per se skilled services). This case was filed on September 22, 2015, in the U.S. District Court for the District of Connecticut. It challenges the denial of Medicare home health coverage for a beneficiary who required monthly Vitamin B-12 intramuscular injections. Intramuscular injections are, by regulation, a per se skilled service, and the beneficiary in this case has a condition (Total Gastrectomy) for which Medicare policy expressly recognizes B-12 injections to be a medically necessary treatment. The Center is interested in hearing about similar problems that others are encountering with respect to denials of home health or SNF coverage for per se skilled services listed at 42 C.F.R. 409.33(b). Advocates and beneficiaries are encouraged to contact Wey-Wey Kwok at wkwok@medicareadvocacy.org.

Other examples of health care services that are defined by Medicare as skilled in either a Skilled Nursing Facility or for Home Health care include:

(1) Intravenous or intramuscular injections and intravenous feeding.

(2) Enteral feeding that comprises at least 26 per cent of daily calorie requirements and provides at least 501 milliliters of fluid per day.

(3) Nasopharyngeal and tracheostomy aspiration;

(4) Insertion and sterile irrigation and replacement of suprapubic catheters;

(9) Rehabilitation nursing procedures, including the related teaching and adaptive aspects of nursing, that are part of active treatment, e.g., the institution and supervision of bowel and bladder training programs.

On December 28, 2015, the government filed a motion to remand the case to the Medicare Appeals Council. On April 29, 2016, the court granted the government’s motion to remand, but retained jurisdiction and ordered defendant to submit a status report on further action taken by the Secretary of Health and Human Services by August 15, 2016.

On June 13, 2016, the Medicare Appeals Council issued a new decision, favorable to the beneficiary. It decided that the monthly Vitamin B-12 injections should be covered, however its rationale was questionable. The Appeals Council stated that the medical records did not “clearly indicate the purpose for giving” the B-12 injections, “nor do most of the skilled nursing visit notes specifically reference the beneficiary’s gastrectomy.” It found coverage as warranted nonetheless because the beneficiary’s plans of care referenced the total gastrectomy. The decision made no reference to the serious problems with the original Appeals Council decision, which theorized that the beneficiary could have performed the intra-muscular injections herself. Despite the favorable ruling, the Center was not satisfied with the reasoning of the Appeals Council.

On August 15, 2016, as required by the court, the government filed a status update which stated that since coverage had been granted the case is now moot. The Center responded with a filing explaining its continuing disagreement with the rationale used by the Appeals Council. On August 16 the court ordered the government to file a motion to dismiss based on its contention that the case is moot.

Update: The motion to dismiss was fully briefed as of November 7, 2016. In opposition the plaintiff contends that the resolution of the single underlying claim did not resolve the policy issue the case sought to address. The parties await a decision from the court.